Paclitaxel plus carboplatin (PC) is noninferior to paclitaxel plus ifosfamide (PI) for patients with uterine carcinosarcoma (UCS), according to a phase 3 trial published in the Journal of Clinical Oncology.
The GOG-0261 trial (ClinicalTrials.gov Identifier: NCT00954174) was designed to test the null hypothesis that survival among patients with UCS or ovarian carcinosarcoma (OCS) who receive PC is inferior to survival among UCS/OCS patients who receive PI.
The trial included 449 patients with UCS and 90 with OCS who were eligible for analysis. The patients were randomly assigned 1:1 to receive PC or PI in 3-week cycles for 6 to 10 cycles. In the UCS cohort, 228 patients received PC and 221 received PI. In the OCS cohort, 44 received PC and 46 received PI.
Overall, most patients were between the ages of 50 and 79 years, and most were non-Hispanic White. More than 60% of patients completed all of their planned treatment. The median time on treatment was 16 weeks from randomization.
For patients with UCS, the median overall survival (OS) was 37.3 months in the PC arm and 29 months in the PI arm (adjusted hazard ratio [aHR], 0.87; 90% CI, 0.70-1.075). PC was noninferior (P <.01) but not superior to PI (P =.14).
For patients with OCS, the median OS was 30 months in the PC arm and 24.7 months in the PI arm (aHR, 1.15; 95% CI, 0.67-1.95). Neither inferiority nor noninferiority could be ruled out.
For patients with UCS, the median progression-free survival (PFS) was 16.3 months in the PC arm and 11.7 months in the PI arm (aHR, 0.735; 95% CI, 0.58-0.93). PC was both noninferior (P <.001) and superior to PI (P <.01) for PFS.
For patients with OCS, the median PFS was 14.6 months in the PC arm and 10.3 months in the PI arm (aHR, 1.01; 95% CI, 0.61-1.67). Inferiority could not be ruled out.
Toxicities were largely similar between the treatment arms. However, the rate of hematologic toxicity was higher in the PC arm than in the PI arm (82% and 50%, respectively; P <.01).
Grade 3-5 neurologic adverse events occurred in 12% of patients in the PI arm and 7% of those in the PC arm (P >.10). Patients in both arms reported a decrease in quality of life and an increase in neurotoxic symptoms during treatment.
“These results establish a new standard regimen — PC — for women with UCS of all stages and especially for stage III patients,” the researchers wrote. “Identifying and targeting the molecular aberrations in these tumors should lead to further improvements in treatment.”
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Powell MA, Filiaci VL, Hensley ML, et al. Randomized phase III trial of paclitaxel and carboplatin versus paclitaxel and ifosfamide in patients with carcinosarcoma of the uterus or ovary: An NRG oncology trial. J Clin Oncol. Published online January 10, 2022. doi:10.1200/JCO.21.02050